Heretofore, sphincter cuffs have been made in a variety of fixed sizes from 4.5 cm in length to 11 cm in length. From 4.5 cm to 7 cm the cuffs come in 0.5 cm size gradations and from 8 cm to 11 cm they come in 1.0 cm size gradations. Thus, six sizes are required from 4.5 cm to 7 cm and four additional sizes from 8 cm to 11 cm; a total of ten different size cuffs. Obviously, a relatively large inventory of these various sizes was necessary to meet all contingencies. There was also the attendant problem of increased manufacturing and inventory costs and potential danger of utilizing or perhaps settling on a size that was not correctly fitted.
Furthermore, a major complaint from artificial sphincter implant patients is the erosion of the urethra at high pressure points. A cuff commercially being sold today consists of four separate "pillows" connected together. The areas between the pillows are open with no closing pressure necessitating the center of the pillow to compensate with extra pressure.